Operator, Aseptic Filling (Day Shift)

Role Summary

Operator, Aseptic Filling (Day Shift) supports start-up activities during the project phase to bring the area into service, including formulation, aseptic isolator barrier filling, and visual inspection. After the project phase, the role ensures continuous supply by expertly running processes, troubleshooting, and collaborating cross-functionally with a safety-first, quality-always mindset. Growth opportunities exist into future leadership and technical roles as a site leader and expert at a growing site.

Responsibilities

• Provide leadership on the manufacturing floor to maintain safety, quality, and productivity for reliable product supply.
• Maintain a safe work environment, exemplify safe practices, and support health, safety, and environmental goals.
• Act as administrator and technical leader for operations; model adherence to procedures, quality systems, and instruction of proper techniques.
• Troubleshoot and operate equipment to meet production schedules; assist in verifying execution documentation (Electronic Batch Records, SAP, Cleaning Logs).
• Drive key departmental objectives including safety improvements, deviation reduction, productivity, and training compliance.
• Administer technical training and ensure operators are trained to perform tasks.
• Support area procedures, quality processes, and controls for PAR operations; coordinate with support functions as needed.
• Develop and mentor team members; contribute to building a diverse and capable site organization.

Qualifications

• Required: High School Diploma or GED
• Required: Valid driver's license
• Required: Fitness for duty physical exam clearance
• Required: Vision exam clearance and no color blindness; 20/20 correctable close vision
• Required: Able to work 6am to 6pm on a 2-2-3 schedule
• Required: Legal authorization to work in the United States (no anticipated sponsorship)

Skills

• Effective written and verbal communication; ability to train and educate team members
• Strong problem-solving and troubleshooting capabilities; flexibility to triage challenges
• Computer proficiency (desktop software, MS Office); familiarity with manufacturing systems
• Leadership ability and experience training others
• Ability to wear safety equipment and work in cleanroom environments (Grade C, ISO 8)
• Experience in operations or manufacturing environments; knowledge of CGMPs
• Understanding of Manufacturing Execution Systems and electronic batch release; SAP / Electronic Batch Records
• Lean, Six Sigma or continuous improvement methodologies
• Experience with aseptic filling, single-use assemblies, isolator technology; automated/manual inspection

Education

• High School Diploma or GED required; STEM degree or certifications preferred

Additional Requirements

• Ability to work overtime as required
• Willingness to participate in professional development opportunities (e.g., RCCC coursework)
• Ability to participate as a site-leader and educator within a growing manufacturing environment